Importation

The Dangers of Imported Medicines

Importing prescription medications can be risky. The prevalence of counterfeit drugs is soaring overseas, growing 118% in 2008 alone. A patient taking a counterfeit medication may not be getting the correct dose or may not be getting any real medicine at all. Especially for patients facing cancer or other life-threatening diseases, the consequences of counterfeit drugs are frightening to contemplate.

Beyond the risk of counterfeit drugs, imported medicines present additional hazards. In the U.S., pharmaceutical manufacturers are held to high standards in all phases of production. The FDA routinely inspects pharmaceutical manufacturing plants to ensure compliance with the agency’s Good Manufacturing Practices[1].

To protect the American public, the FDA requires that prescription drugs in the U.S. be shown to be both safe and effective prior to being sold. Throughout the drug approval process, pharmaceutical manufacturers must prove that they can consistently produce medications of expected strength, quality, and purity. The FDA also reviews labeling to ensure healthcare professionals and patients have the information necessary to understand a drug's risks and proper use.

• Quality assurance concerns. Medications that have not been approved for sale in the U.S. may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.

• Presence of untested substances. Imported medications and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness with the same rigor we use for drug approval in the U.S. These products may be addictive or contain other dangerous substances.

• Risks of unsupervised use. Some medications, whether imported or not, are unsafe when taken without adequate medical supervision. You may need a medical evaluation to ensure that the medication is appropriate for you and your condition. Or, you may require medical checkups to make sure that you are taking the drug properly, it is working for you, and that you are not having unexpected or life-threatening side effects.

• Labeling and language issues. The medication's label, including instructions for use and possible side effects, may be in a language you don’t understand or may make medical claims and suggest specific uses that have not been adequately evaluated for safety and effectiveness.

• Lack of information. An imported medication may lack information that would permit you to be promptly and correctly treated for an allergic reaction or dangerous side effect caused by the drug.

Help with Prescription Drug Costs

Patients facing high medical costs can be especially vulnerable to deception by illegitimate pharmacy sites selling imported medicines. At PhRMA, we recognize the importance of drug affordability. The high standards in the U.S. for drug research, medical clinical trials, and pharmaceutical manufacturing contribute to the plethora of excellent medications available to Americans, as well as to their costs.

Recently some state and local governments have attempted to reduce drug costs through importation programs. These programs, though well-intentioned, actually ended up costing taxpayers millions of dollars. For this reason, the programs were eventually shut down.

Fortunately there are safer, better ways to afford prescription drugs. Medicare helps millions of seniors and disabled citizens pay for the medications that will prolong and improve their lives. The pharmaceutical industry has also taken a leading role in prescription assistance through the creation of the Partnership for Prescription Assistance[3] (PPA). The PPA has helped nearly eight million uninsured and underinsured Americans access patient assistance programs that provide free or nearly free medicines. Patients can get more information about PPA by calling 1-888-4PPA-NOW or by visiting its web site at www.pparx.org[4].